Clinical Trials

Date: 2021-02-03

Type of information: Treatment of the first patient

phase: 3

Announcement: treatment of the first patient

Company: Vectivbio (Switzerland)

Product: apraglutide

Action mechanism: GLP-2 analog This next-generation GLP-2 analog is being developed for the treatment of short bowel syndrome (SBS). Patients with severe SBS require lifelong intravenous delivery of essential nutrients, referred to as parenteral support, for survival. Apraglutide aims to increase the intestine’s ability to absorb fluids and nutrients, thereby minimizing the burden of parenteral support. With a once-weekly dosing regimen, apraglutide is designed to have best-in-class properties with the goal of improving patients’ quality of life and their ability to thrive. In addition, apraglutide’s development program is designed to generate evidence of meaningful clinical benefit based on patients’ underlying intestinal anatomy in order to enable a patient-tailored treatment approach.

Disease: short bowel syndrome

Therapeutic area: Inflammatory diseases - Gastrointestinal diseases

Country: Argentina, Belgium, Czechia, France, Germany, Israel, Italy, Japan, republic of Korea, Poland, Spain, Sweden, Taiwan, UK, USA

Trial details: The phase 3 STARS (STudy of ApRaglutide in SBS) trial (NCT04627025) is a global clinical trial that represents the largest phase 3 trial ever conducted in short bowel syndrome with intestinal failure (SBS-IF). STARS is the first trial of a next-generation, long-acting GLP-2 analog, designed to exclusively evaluate a once-weekly dosing interval and to take into account remnant bowel anatomy and individual caloric needs during weaning patients off of parenteral support. The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase.

Latest news:

  • On February 3, 2021, VectivBio, a clinical-stage biotechnology company developing innovative treatments for severe rare conditions with high unmet medical need, announced that the first patient has been dosed in its pivotal phase 3 trial of apraglutide in short bowel syndrome (SBS). The phase 2 clinical program for apraglutide included two independent trials evaluating the safety and efficacy of once-weekly administration in patients with SBS. Apraglutide was found to be safe and well tolerated in both trials and achieved clinically meaningful improvement in intestinal fluid and nutrient absorption compared with placebo. The trials supported the potential advantages of apraglutide on energy absorption to improve outcomes for patients with SBS. These data, as well as those from a metabolic balance trial, were presented at the 2020 ESPEN Virtual Congress and are available in Clinical Nutrition ESPEN.

Is general: Yes